NCT00613080|CompletedPhase 2ResultsDMC

Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer

Radiation Therapy Oncology Group ClinicalTrials.gov

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2 other identifiers

RTOG-0822CDR0000586277

Study Type

interventional

Target

Locations

2 countries

Sites

120

Timeline

RegisteredFeb 2008

StartedApr 2008

CompletionDec 2016

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline

Completed

Started Apr 2008

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach

2 countries

120 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.7 years study duration

First Submitted

Initial submission to the registry

February 9, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed

2 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

3.4 years until next milestone

Results Posted

Study results publicly available

June 10, 2013

Completed

3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

Last Updated

September 25, 2018

Status Verified

July 1, 2018

Enrollment Period

1.8 years

First QC Date

February 9, 2008

Results QC Date

April 12, 2013

Last Update Submit

August 27, 2018

Conditions

Colorectal Cancer

Keywords

stage III rectal canceradenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events \<= 90 days from the start of concurrent treatment are included.
From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)

Secondary Outcomes (8)

Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Pretreatment
Number of Patients With Pathologic Complete Response
At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0
From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
Local-regional Failure: 4-year Rate
From registration to four years
Distant Failure: 4-year Rate
From registration to four years
+3 more secondary outcomes

Study Arms (1)

IMRT + Chemotherapy , Resection, Postoperative Chemotherapy

OTHER

Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)

Drug: capecitabineDrug: oxaliplatinProcedure: resectionRadiation: radiation therapyDrug: FOLFOX