Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer (PROArCT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Trans-Tasman Radiation Oncology Group (TROG).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Trans-Tasman Radiation Oncology Group (TROG)
Information provided by:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT01013805
First received: October 8, 2009
Last updated: November 13, 2009
Last verified: November 2009
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Purpose
The aims of the trial are (1) to determine the tolerability rate in the setting of a multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and complete pathologic response rate in patients with locally advanced rectal cancer who are treated with an integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Radiation: External Beam Radiotherapy Drug: Oxaliplatin Drug: Fluorouracil Drug: Leucovorin Procedure: Surgical Resection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Integrated Preoperative Radiotherapy and Chemotherapy With Oxaliplatin 5-FU and Folinic Acid in Patients With Locally Advanced Rectal Cancer |
Resource links provided by NLM:
Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):
Primary Outcome Measures:
- Tolerability Rate of patients treated with integrated pre-operative radiotherapy with FOLFOX chemotherapy regimen [ Time Frame: End of preoperative treatment (11 weeks) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Complete pathologic response rate following the completion of treatment [ Time Frame: Determined post-surgery ] [ Designated as safety issue: No ]
- Treatment Related Toxicity rates [ Time Frame: Determined after preoperative treatment and 30 days post-surgery ] [ Designated as safety issue: Yes ]
- Dose Intensity of the treatment drug [ Time Frame: End of preoperative treatment (11 weeks) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Integrated Preoperative Radiotherapy and Chemotherapy
|
Radiation: External Beam Radiotherapy
Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy. Weeks 8-10: as per Weeks 3-5 Other Names:
Drug: Oxaliplatin
Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU). Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1. Week 1: (after Oxaliplatin and leucovorin)5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1. Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1. Leucovorin 200 mg/m2 Day 1 concurrent with Oxaliplatin over 2 hrs, then 2nd: 5-FU 400 mg/m2 bolus Day 1, then 3rd: 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1 Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU) Week 6: as per Week 1, Weeks 11: as per Week 1.
Procedure: Surgical Resection
Surgery is to be performed according to the standard procedure for locally advanced rectal cancer 4 to 6 weeks after completion of the integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Previously untreated and pathologically proven adenocarcinoma of the rectum.
- MRI staged T3 or T4, any N.
- Lower border of tumour must be within 12 cm of anal verge.
- Age greater than or equal to 18 years.
- ECOG Performance Status 0-1 (Appendix 2)
- Absolute neutrophil count greater than or equal to 1.5 x 109/L, haemoglobin greater than or equal to 90 g/L, and platelets greater than or equal to 100 x 109/L.
- Adequate renal function: GFR greater than or equal to 55 mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques).
- Bilirubin and ALT less than or equal to 1.5 x upper limit of normal.
- No symptomatic peripheral neuropathy greater than or equal to grade 2.
- Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive.
- Has provided written informed consent for participation in this trial
Exclusion Criteria:
- Presence of metastatic disease.
- Prior pelvic radiotherapy
- Febrile intercurrent illness or infection.
- Previous history of unstable angina
- Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
- Acute coronary syndrome even if controlled with medication
- Myocardial infarction within the last 12 months
- Concurrent treatment with other anti-cancer therapy.
- Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
- Locally recurrent rectal cancer.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013805
Contacts
| Contact: Bev McClure | +61 3 9656 1111 | Bev.McClure@petermac.org |
Locations
| Australia, Victoria | |
| Peter MacCallum Cancer Centre | Not yet recruiting |
| Melbourne, Victoria, Australia, 8006 | |
| Contact: Sam Ngan +61 3 9656 1111 Sam.Ngan@petermac.org | |
| Contact: Bev McClure +61 3 9656 1111 Bev.McClure@petermac.org | |
| Principal Investigator: Sam Ngan | |
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
| Study Chair: | Sam Ngan | Trans-Tasman Radiation Oncology Group (TROG) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Trans Tasman Radiation Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01013805 History of Changes |
| Other Study ID Numbers: | TROG 09.01 |
| Study First Received: | October 8, 2009 |
| Last Updated: | November 13, 2009 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
|
Rectal Cancer Chemotherapy Radiotherapy |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Leucovorin Levoleucovorin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013