Adjuvant Treatment of Concurrent RT and CAPOX or Capecitabine Alone for Stage II and III Rectal Cancer

NCT00714077 | Unknown DMC

• 1 other identifier: CAMS_rectal cancer_01
• Study Type: observational
• Target: 570
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is:

• To compare the long-term of survival and local/regional control between the two postoperative concurrent chemoradiotherapy regimens: capecitabine vs. oxaliplatin and capecitabine,for stage II and III rectal cancer
• To compare the toxicity profile between the two different concurrent chemoradiotherapy regimens.

Conditions

Rectal Neoplasms

Keywords

rectal cancer; concurrent chemoradiotherapy; adjuvant therapy; phase III study

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival rate

  the day of surgery to the date of the event

Secondary Outcomes (5)

• overall survival rate

  the day of surgery to the date of death or last follow-up

• cumulative incidence of local recurrence

  the day of surgery to the date of local recurrence

• cumulative incidence of distant metastasis

  the day of surgery to the date of distant metastasis

• compliance

  during adjuvant radiotherapy and chemotherapy

• safety

  the day of randomization to the date of death or last follow-up

Study Arms (2)

adjuvant capecitabine

To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer

adjuvant oxaliplatin and capecitabine

To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multicenter patients enrollment

You may qualify if:

• years old,male or female
• R0 surgery
• Pathologically approved as stage II or stage III
• Enrolled within 6 months from the date of surgery
• Upper border of tumor before surgery was under L5
• KPS\>70% or ECOG 0-2
• No prior radiotherapy in the past 6 months
• Received chemotherapy no more than 4 cycles after surgery
• HGB\>100 g/L, WBC≥3.5x109 /L, PLT≥100x109 /L; CR\<1.5 x Upper normality，TB\<2.5 X Upper normality，AST or ALT\<2.5 x Upper normality，AKP\<2.5 X Upper normality
• Signed consent

You may not qualify if:

• Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer
• Pregnancy or in lactation
• HGB\<100 g/L, WBC\<3.5x109 /L, PLT\<100x109 /L; CR≥1.5 x Upper normality，TB≥2.5 X Upper normality，AST or ALT≥2.5 x Upper normality，AKP≥2.5 X Upper normality

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Zhejiang Cancer Hospital: collaborator
• Cancer Hospital of Guizhou Province: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Peking University Third Hospital: collaborator
• General Hospital of Chinese Armed Police Forces: collaborator
• Beijing Hospital: collaborator

Study Sites (2)

Jing Jin

Beijing, Beijing Municipality, 100021, China

RECRUITING

Jing Jin

Beijing, Beijing Municipality, 100021, China

RECRUITING

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MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yexiong Li, M.D.

  CAMS

  PRINCIPAL INVESTIGATOR

• Jing Jin, M.D.;Ph.D

  CAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Jin, M.D.

CONTACT

861087788280; jingjin1025@163.com

Yexiong Li, M.D.

CONTACT

861087788860; yexiong12@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 14, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

CN (2)