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Multicenter, Prospective, RCT:Investigation of Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03042000
Recruitment Status : Not yet recruiting
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Collaborators:
Beijing Hospital
Beijing Chao Yang Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking University People's Hospital
Beijing Cancer Hospital
Beijing Friendship Hospital
Geneplus-Beijing Co. Ltd.
Information provided by (Responsible Party):
Guole Lin, Peking Union Medical College Hospital

Brief Summary:

At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy (NCRT) followed by radical surgery has become the standard of care for the locally advanced mid/low rectal cancer, having been proved to substantially improve the local control of the disease, whereas not being able to improve the long-term survival. According to present clinical practice guidelines, all patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer are recommended to undergo the preoperative long-term radiotherapy with concurrent 5FU based chemotherapy, followed by the radical resection of the tumor. After surgery, adjuvant chemotherapy (ACT) is recommended for all these patients without considering the postoperative pathological results. Recently, however, some authors proposed that different strategy of combined modality therapy should be applied in different patients according to their risk of relapse, instead of using the uniform NCRT strategy. In this research, on the basis of investigator's previous clinical practice and researches, investigators plan to stratify the patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer into several subgroups according to tumor stages and the risk of relapse. Different therapeutic strategy will be applied in different groups, at the aim of improving the overall therapeutic effects, as well as reducing the treatment adverse effects.

This research consists of four trials.


Condition or disease Intervention/treatment Phase
Rectal Cancer, Adenocarcinoma Neoadjuvant Chemoradiation Other: non-NCRT Other: NCRT Drug: capecitabine with oxaliplatin Drug: capecitabine Procedure: TEM Procedure: radical resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer.
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Group A1
Patients with cT3a-bN0-1aM0 mid rectal cancer who undergo the treatment modality of 'radical surgery + adjuvant chemotherapy (ACT)'
Other: non-NCRT
without the preoperative concurrent chemoradiothearpy (no neoadjuvant chemoradiation)

Active Comparator: Group A2
Patients with cT3a-bN0-1aM0 mid rectal cancer who undergo the treatment modality of 'NCRT + radical surgery + ACT'
Other: NCRT
the preoperative concurrent chemoradiothearpy (neoadjuvant chemoradiation)

Experimental: Group B1
Patients with cT4NanyM0 or cTanyN2M0 mid/low rectal cancer who undergo the treatment modality of 'NCRT with combined chemotherapy (Capox regimen) + radical surgery + ACT'
Drug: capecitabine with oxaliplatin
combined chemotherapy with capecitabine with oxaliplatin

Active Comparator: Group B2
Patients with cT4NanyM0 or cTanyN2M0 mid/low rectal cancer who undergo the treatment modality of 'NCRT with single-agent chemotherapy (Capecitabine) + radical surgery + ACT'
Drug: capecitabine
single-agent chemotherapy with capecitabine

Experimental: Group C1
Patients with locally advanced rectal cancer, being clinically staged cCR after NCRT, who undergo the transanal endoscopic microsurgery (TEM) excision of the lesion.
Procedure: TEM
transanal endoscopic microsurgery (TEM) excision of the lesion

Active Comparator: Group C2
Patients with locally advanced rectal cancer, being clinically staged cCR after NCRT, who undergo the radical resection of the lesion.
Procedure: radical resection
radical resection of rectal cancer




Primary Outcome Measures :
  1. 3y-DFS [ Time Frame: 3 years ]
    the 3-year disease free survival rate


Secondary Outcome Measures :
  1. 3y-OS [ Time Frame: 3 years ]
    the 3-year overall survival rate

  2. 5y-DFS [ Time Frame: 5 years ]
    the 5-year disease free survival rate

  3. 5y-OS [ Time Frame: 5 years ]
    the 5-year overall survival rate

  4. pCR [ Time Frame: 4 months ]
    pathological complete tumor response rate



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients aged 18 to 75 years old. Patients with cT3-4N0M0 or cTanyN+M0 mid/low rectal cancer. Patients with ASA physical status scroe of I to III. Patients who can fully understand the content of the informed consent form and sign it upon their own opinions.

Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-ups.

Exclusion Criteria:

Patient has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosis etc.).

Patient is pregnant or lactating. Patient has a history of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma in a non-mucosal, ultraviolet exposed area, or cervical carcinoma.

Patient is participating in any other clinical trials within 30 days prior to screening.

Patient has severe mental illness. Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042000


Contacts
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Contact: Jiaolin Zhou, MD. 8613910136704 conniezhjl@163.com
Contact: Guole Lin, MD. 861069152211 linglpumch@163.com

Sponsors and Collaborators
Peking Union Medical College Hospital
Beijing Hospital
Beijing Chao Yang Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking University People's Hospital
Beijing Cancer Hospital
Beijing Friendship Hospital
Geneplus-Beijing Co. Ltd.
Publications:
Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

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Responsible Party: Guole Lin, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03042000    
Other Study ID Numbers: PUMCH-Colorectal Surgery 02
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guole Lin, Peking Union Medical College Hospital:
rectal cancer
neoadjuvant chemoradiation
circulating tumor DNA
local recurrence
long-term survival
Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents