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Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients


Phase 1
76 Years
N/A
Open (Enrolling)
Both
Rectal Neoplasms

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Trial Information

Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients


It is proved that preoperative concurrent chemo-radiotherapy can improve both local control
and overall survival in stage II/III rectal cancer patients. But elderly patients,
especially patients over 75 years were hardly involved in related clinical trials considered
of their fragility.

Several retrospective study showed that old rectal cancer patients would also benefit from
concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as
capecitabine, also seem to be safety for elderly cancer patients. But few prospective study
has been carried out.

The investigators designed this phase I study, to explore the maximum tolerant dose of
capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal
cancer patients, as well as to evaluate safety.


Inclusion Criteria:



- rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).

- KPS status no less than 70; Charlson comorbidity no more than 3.

- life expectancy more than 6 months.

- hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L,
platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal,
AKP normal.

- do not have allergy history to thymidine phosphorylase.

- do not receive surgery ( except palliative colostomy) or chemotherapy or other
anti-cancer treatment

- no previously pelvic irradiation history

- informed consent signed

Exclusion Criteria:

- other cancer history, except curable non-melanoma skin cancer or cervix in-situ
carcinoma

- previous pelvic irradiation history

- receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer
treatment

- allergy history to thymidine phosphorylase

- active infection existed

- severe complication, such as acute myocardial infarction in 6 months, uncontrolled
diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe
cardiac arrhythmia， etc.

- anticipate other clinical trials in four weeks before enrollment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of patients suffering dose limited toxicity

Outcome Description:

more than 1/3 patients suffer DLT means the end of the trial.dose related toxicity is defined as follows:1. luecopenia > grade 2; granular cell decrease > grade 2; anemia > grade 1; platelet > grade 1;SGPT/SGOT elevation > grade 1; ALP > grade 1; GGT > grade 1; Tbil > grade 1;renal function damag > grade 2;Non-gradular cell decreased fever > grade 1;nausea/vomiting > grade 1; fatigue > grade 2; weight loss > grade 2;gastritis > grade 2; dairrea > grade 2; abdominal pain > grade 2; upper gastrointestinal bleeding > grade 1;other toxic reaction > grade 2;KPS < 50 during the treatment

Outcome Time Frame:

up to 7 weeks from start of the treatment

Safety Issue:

Yes

Principal Investigator

Jing Jin, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese Academic Medical Science

Authority:

China: Food and Drug Administration

Study ID:

CH-GI-024

NCT ID:

NCT01584544

Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Rectal Neoplasms
  • rectal neoplasms
  • aged
  • chemoradiotherapy
  • clinical trials, phase I
  • capecitabine
  • Neoplasms
  • Rectal Neoplasms

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